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Betadine Gargle & Mouthwash


1. Name Of The Medicinal Product

Betadine Gargle and Mouthwash.

2. Qualitative And Quantitative Composition

Povidone Iodine USP 1% w/v (equivalent to 0.1% w/v of available iodine).

3. Pharmaceutical Form

Solution.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of acute mucosal infections of the mouth and pharynx, for example gingivitis, and mouth ulcers. For oral hygiene prior to, during and after dental and oral surgery.

4.2 Posology And Method Of Administration

For oral administration, as a gargle and mouthwash. The product should not be swallowed. Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10ml for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as directed.

4.3 Contraindications

Not for use in children under 6 years of age and in patients with a known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

4.4 Special Warnings And Precautions For Use

Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days, seek medical or dental advice. Regular use should be avoided in patients on concurrent lithium therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone iodine may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

4.6 Pregnancy And Lactation

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development. The use of Betadine Gargle and Mouthwash in pregnant and lactating women should be limited to a single treatment session only.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Idiosyncratic mucosal irritation and hypersensitivity reactions may occur. Excessive absorption of iodine may produce systemic effects such as metabolic acidosis, hypernatraemia and impairment of renal function.

4.9 Overdose

Excessive iodine can produce goitre and hypothyroidism or hyperthyroidism. Acute overdose may result in symptoms of metallic taste in the mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling in the eyes, difficulty in breathing due to pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea. Metabolic acidosis, hypernatraemia and renal impairment may occur. Treatment: In the cases of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Betadine Gargle and Mouthwash contains povidone iodine, a complex of iodine which shows all the broad spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. Betadine Gargle and Mouthwash kills bacteria, viruses, fungi, spores and protozoa.

5.2 Pharmacokinetic Properties

The product is intended for topical application to the mouth and buccal cavity.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol; menthol; methyl salicylate; ethanol 96%; saccharin sodium; purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store in a dry place below 25oC. Protect from light.

6.5 Nature And Contents Of Container

Amber soda-lime-silica glass bottle (USP Type III) fitted with an externally ribbed white urea cap, with a steran faced wad or with a wadless polypropylene cap containing 250ml of product.

6.6 Special Precautions For Disposal And Other Handling

This product should not be swallowed.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0006.

9. Date Of First Authorisation/Renewal Of The Authorisation

30th September 2005.

10. Date Of Revision Of The Text

September 2005.


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Iopox


Iopox may be available in the countries listed below.

Ingredient matches for Iopox Povidone Iodine

Povidone-Iodine is reported as an ingredient of Iopox in the following countries:

Argentina

International Drug Name Search


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Iodomax


Iodomax may be available in the countries listed below.

Ingredient matches for Iodomax Povidone Iodine

Povidone-Iodine is reported as an ingredient of Iodomax in the following countries:

Argentina

International Drug Name Search


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Jodi gel


Jodi gel may be available in the countries listed below.

Ingredient matches for Jodi gel Povidone Iodine

Povidone-Iodine is reported as an ingredient of Jodi gel in the following countries:

Poland

International Drug Name Search


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JD


JD may be available in the countries listed below.

Ingredient matches for JD Glycerol

Glycerol is reported as an ingredient of JD in the following countries:

Japan Povidone Iodine

Povidone-Iodine is reported as an ingredient of JD in the following countries:

Japan

International Drug Name Search


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Povidone/Iodine Cream


Pronunciation: POE-vi-done/EYE-oh-dine
Generic Name: Povidone/Iodine
Brand Name: Examples include Betadine and Pharmadine
Povidone/Iodine Cream is used for:

Treating minor wounds and infections, as well as killing bacteria.

Povidone/Iodine Cream is an antiseptic combination. It works by killing sensitive bacteria.

Do NOT use Povidone/Iodine Cream if: you are allergic to any ingredient in Povidone/Iodine Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Povidone/Iodine Cream:

Some medical conditions may interact with Povidone/Iodine Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have serious burns or deep puncture wounds

Some MEDICINES MAY INTERACT with Povidone/Iodine Cream. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Povidone/Iodine Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Povidone/Iodine Cream:

Use Povidone/Iodine Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Clean the affected area. Apply a small amount of Povidone/Iodine Cream to the affected area. The area may be left uncovered, or you may cover it with a sterile bandage. If you miss a dose of Povidone/Iodine Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Povidone/Iodine Cream.

Important safety information: If you have had a severe allergic reaction to Povidone/Iodine Cream or a medicine that contains iodine, contact your doctor or pharmacist immediately. A severe allergic reaction includes a severe rash, hives, difficulty breathing, or dizziness. If you have questions about whether you are allergic to Povidone/Iodine Cream or if a certain medicine contains iodine, contact your doctor or pharmacist. If you experience a skin rash, hives, or itching, or any other unusual reaction after using this product, discontinue use and contact your doctor as soon as possible. Povidone/Iodine Cream is for external use only. Do not get Povidone/Iodine Cream in your eyes. Do not use Povidone/Iodine Cream over large areas of the body or for more than 1 week unless advised to do so by your doctor. Contact your doctor before using Povidone/Iodine Cream on serious burns, deep wounds, or puncture wounds. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Povidone/Iodine Cream, discuss with your doctor the benefits and risks of using Povidone/Iodine Cream during pregnancy. It is unknown if Povidone/Iodine Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Povidone/Iodine Cream, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Povidone/Iodine Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Skin irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Povidone/Iodine Cream:

Store Povidone/Iodine Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Povidone/Iodine Cream out of the reach of children and away from pets.

General information: If you have any questions about Povidone/Iodine Cream, please talk with your doctor, pharmacist, or other health care provider. Povidone/Iodine Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Povidone/Iodine Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Povidone/Iodine resources Povidone/Iodine Use in Pregnancy & Breastfeeding Povidone/Iodine Support Group 0 Reviews · Be the first to review/rate this drug
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Povidone/Iodine Shampoo


Pronunciation: POE-vi-done/EYE-oh-dine
Generic Name: Povidone/Iodine
Brand Name: Betadine
Povidone/Iodine Shampoo is used for:

Cleansing the hair and scalp to reduce the risk of infection.

Povidone/Iodine Shampoo is an antiseptic combination. It works by killing sensitive bacteria.

Do NOT use Povidone/Iodine Shampoo if: you are allergic to any ingredient in Povidone/Iodine Shampoo

Contact your doctor or health care provider right away if any of these apply to you.

Before using Povidone/Iodine Shampoo:

Some medical conditions may interact with Povidone/Iodine Shampoo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have serious burns or deep puncture wounds

Some MEDICINES MAY INTERACT with Povidone/Iodine Shampoo. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Povidone/Iodine Shampoo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Povidone/Iodine Shampoo:

Use Povidone/Iodine Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

To use Povidone/Iodine Shampoo on the scalp, massage 1 or 2 teaspoonfuls into the wet scalp. Leave on the scalp for up to 10 minutes. Rinse the scalp thoroughly. Wash your hands well after using Povidone/Iodine Shampoo. If you miss a dose of Povidone/Iodine Shampoo, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Povidone/Iodine Shampoo.

Important safety information: If you have had a severe allergic reaction to Povidone/Iodine Shampoo or a medicine that contains iodine, contact your doctor or pharmacist immediately. A severe allergic reaction includes a severe rash, hives, difficulty breathing, or dizziness. If you have questions about whether you are allergic to Povidone/Iodine Shampoo or if a certain medicine contains iodine, contact your doctor or pharmacist. If you experience a skin rash, hives, or itching, or any other unusual reaction after using this product, discontinue use and contact your doctor as soon as possible. Povidone/Iodine Shampoo is for external use only. Do not get Povidone/Iodine Shampoo in your eyes, nose, or mouth. Do not use Povidone/Iodine Shampoo over large areas of the body or for more than 1 week unless advised to do so by your doctor. Contact your doctor before using Povidone/Iodine Shampoo on serious burns, deep wounds, or puncture wounds. Use Povidone/Iodine Shampoo with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Povidone/Iodine Shampoo, discuss with your doctor the benefits and risks of using Povidone/Iodine Shampoo during pregnancy. It is unknown if Povidone/Iodine Shampoo is excreted in breast milk. If you are or will be breast-feeding while you are using Povidone/Iodine Shampoo, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Povidone/Iodine Shampoo:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Skin irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); worsening of your condition.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Povidone/Iodine Shampoo:

Store Povidone/Iodine Shampoo at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Povidone/Iodine Shampoo out of the reach of children and away from pets.

General information: If you have any questions about Povidone/Iodine Shampoo, please talk with your doctor, pharmacist, or other health care provider. Povidone/Iodine Shampoo is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Povidone/Iodine Shampoo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Povidone/Iodine resources Povidone/Iodine Use in Pregnancy & Breastfeeding Povidone/Iodine Support Group 0 Reviews · Be the first to review/rate this drug
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Povidone/Iodine Solution


Pronunciation: POE-vi-done/EYE-oh-dine
Generic Name: Povidone/Iodine
Brand Name: Examples include Minidyne and Polydine
Povidone/Iodine Solution is used for:

Treating minor wounds and infections, as well as killing bacteria.

Povidone/Iodine Solution is an antiseptic combination. It works by killing sensitive bacteria.

Do NOT use Povidone/Iodine Solution if: you are allergic to any ingredient in Povidone/Iodine Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Povidone/Iodine Solution:

Some medical conditions may interact with Povidone/Iodine Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have serious burns or deep puncture wounds

Some MEDICINES MAY INTERACT with Povidone/Iodine Solution. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Povidone/Iodine Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Povidone/Iodine Solution:

Use Povidone/Iodine Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Clean the affected area. Apply a small amount of Povidone/Iodine Solution to the affected area. The area may be left uncovered, or you may cover it with a sterile bandage. If you miss a dose of Povidone/Iodine Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Povidone/Iodine Solution.

Important safety information: If you have had a severe allergic reaction to Povidone/Iodine Solution or a medicine that contains iodine, contact your doctor or pharmacist immediately. A severe allergic reaction includes a severe rash, hives, difficulty breathing, or dizziness. If you have questions about whether you are allergic to Povidone/Iodine Solution or if a certain medicine contains iodine, contact your doctor or pharmacist. If you experience a skin rash, hives, or itching, or any other unusual reaction after using this product, discontinue use and contact your doctor as soon as possible. Povidone/Iodine Solution is for external use only. Do not get Povidone/Iodine Solution in your eyes, nose, or mouth. Do not use Povidone/Iodine Solution over large areas of the body or for more than 1 week unless advised to do so by your doctor. Contact your doctor before using Povidone/Iodine Solution on serious burns, deep wounds, or puncture wounds. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Povidone/Iodine Solution, discuss with your doctor the benefits and risks of using Povidone/Iodine Solution during pregnancy. It is unknown if Povidone/Iodine Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Povidone/Iodine Solution, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Povidone/Iodine Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Skin irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Povidone/Iodine Solution:

Store Povidone/Iodine Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Povidone/Iodine Solution out of the reach of children and away from pets.

General information: If you have any questions about Povidone/Iodine Solution, please talk with your doctor, pharmacist, or other health care provider. Povidone/Iodine Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Povidone/Iodine Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Povidone/Iodine resources Povidone/Iodine Use in Pregnancy & Breastfeeding Povidone/Iodine Support Group 0 Reviews · Be the first to review/rate this drug
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Jod-Polyvidon Wund- und Brandsalbe CT


Jod-Polyvidon Wund- und Brandsalbe CT may be available in the countries listed below.

Ingredient matches for Jod-Polyvidon Wund- und Brandsalbe CT Povidone Iodine

Povidone-Iodine is reported as an ingredient of Jod-Polyvidon Wund- und Brandsalbe CT in the following countries:

Germany

International Drug Name Search


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Jod-Polyvidon Wund- und Brandsalbe


Jod-Polyvidon Wund- und Brandsalbe may be available in the countries listed below.

Ingredient matches for Jod-Polyvidon Wund- und Brandsalbe Povidone Iodine

Povidone-Iodine is reported as an ingredient of Jod-Polyvidon Wund- und Brandsalbe in the following countries:

Germany

International Drug Name Search


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VIDENE ALCOHOLIC TINCTURE (Ecolab)


1. Name Of The Medicinal Product

VIDENE ALCOHOLIC TINCTURE

2. Qualitative And Quantitative Composition

Povidone-iodine 10% w/w

3. Pharmaceutical Form

Topical Solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Videne Alcoholic Tincture is a broad-spectrum antiseptic for topical application. It is indicated for quick-drying pre-operative skin disinfection, particularly in orthopaedic surgery.

4.2 Posology And Method Of Administration

Videne Alcoholic Tincture is applied undiluted to the area to be incised and painted on thoroughly using a gauze swab. The solution may be allowed to dry to form a protective film or may be removed using a sterile gauze swab.

There are no special dosage recommendations for children or elderly patients.

4.3 Contraindications

Videne Alcoholic Tincture must never be administered orally.

4.4 Special Warnings And Precautions For Use

Care should be taken with known iodine-sensitive subjects, although such people do not normally react to povidone-iodine.

Videne Alcoholic Tincture must not be used on broken skin because of the intense stinging caused by the alcohol present.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Videne Alcoholic Tincture is not recommended for use during pregnancy because of the possibility of absorption through broken skin and subsequent interference with tests of neonatal thyroid function.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

In very rare instances Videne Alcoholic Tincture may produce skin reactions in iodine-sensitive subjects. These reactions subside on cessation of treatment.

4.9 Overdose

In cases where Videne Alcoholic Tincture has been taken orally, gastric lavage with dilute starch mucilage or a 1% solution of sodium thiosulphate must be administered. The electrolyte balance must be corrected and lost fluids replaced.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Povidone-iodine has antiseptic activity and is used mainly for the treatment of contaminated wounds and preparation of pre-operative skin and mucous membranes. It is considered to be less irritant than iodine.

5.2 Pharmacokinetic Properties

Povidone-iodine is slightly absorbed when applied to the skin. Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and sweat.

5.3 Preclinical Safety Data

Povidone-iodine had a low acute toxicity in both dogs and rats following either oral or intraperitoneal administration. Absorption of iodine through intact skin is low following the application of solutions of povidone-iodine although systemic absorption of iodine is greatly increased if the solutions are applied to broken skin, mucous membranes or are introduced into cavities of the body. At subcutaneous dose levels of up to 75mg/kg/day, povidone-iodine was non-teratogenic in rabbits following administration to pregnant animals during the period of organogenesis.

Some early in vitro studies indicated a possible mutagenic action for povidone-iodine. However, a number of later studies, using in vitro and in vivo test systems, do not indicate a significant level of mutagenic/genotoxic activity for povidone-iodine. Although conflicting data have been published, there is no convincing evidence to suggest that povidone-iodine adversely affects wound healing. Concentration of 0.05 and 0.5% povidone-iodine did not cause significant ocular damage when administered into the vitreous cavities of rabbits' eyes. There is some evidence to suggest that povidone-iodine-containing solutions applied to the round window of the chinchilla ear could result in high frequency hearing loss.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Alkyl Phenol Ether Sulphate (ammonium salt)

Industrial Methylated Spirit 95%

Citric Acid

Di-sodium Phosphate, Anhydrous

Purified Water

6.2 Incompatibilities

None stated

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 20°C in a dry place, protected from light.

6.5 Nature And Contents Of Container

Videne Alcoholic Tincture is packaged in a 500 ml HDPE bottle sealed with a plastic screw cap.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0040

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 2003

10. Date Of Revision Of The Text

August 2006


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VIDENE SURGICAL SCRUB (Ecolab)


1. Name Of The Medicinal Product

VIDENE SURGICAL SCRUB

2. Qualitative And Quantitative Composition

Povidone-iodine 7.5% w/w

3. Pharmaceutical Form

Topical solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Videne Surgical Scrub is a broad-spectrum antiseptic for topical use. It is indicated for pre-operative hand disinfection by the surgical team, or for disinfecting the site of incision prior to elective surgery.

4.2 Posology And Method Of Administration

Pre-operative surgical scrub - after first wetting the hands and arms with water, approximately 3.5 ml of Videne Surgical Scrub is applied and rubbed thoroughly on to these areas. A brush may be used to scrub the nails. A little water is added to develop a lather and finally this is rinsed off with running water.

Pre-operative skin preparation - the site of incision should be washed with Videne Surgical Scrub two or three times a day for at least two days prior to the operation. Immediately before surgery the skin should be moistened with water, Videne Surgical Scrub applied and rubbed thoroughly into the area for several minutes. A sterile gauze swab is used to develop a lather which is finally rinsed off with water.

Only water should be used to dilute Videne Surgical Scrub.

There are no special dosage recommendations for children or elderly patients.

4.3 Contraindications

Videne Surgical Scrub must never be administered orally.

4.4 Special Warnings And Precautions For Use

Care should be taken when Videne Surgical Scrub is used on known iodine-sensitive subjects, although such people do not normally react to povidone-iodine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Videne Surgical Scrub is not recommended for use during pregnancy because of the possibility of absorption through broken skin and subsequent interference with tests of neonatal thyroid function.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

In very rare instances Videne Surgical Scrub may produce skin reactions in iodine-sensitive subjects. These reactions subside on cessation of treatment.

4.9 Overdose

In cases where Videne Surgical Scrub has been taken orally, gastric lavage with dilute starch mucilage or a 1% solution of sodium thiosulphate must be administered. The electrolyte balance must be corrected and lost fluids replaced.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Povidone-iodine has antiseptic activity and is used mainly for the treatment of contaminated wounds and pre-operative preparation of skin and mucous membranes. It is considered to be less irritant than iodine.

5.2 Pharmacokinetic Properties

Povidone-iodine is slightly absorbed when applied to the skin. Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and sweat.

5.3 Preclinical Safety Data

Povidone-iodine had a low acute toxicity in both dogs and cats following either oral or intraperitoneal administration. Absorption of iodine through intact skin is low following the application of solutions of povidone-iodine although systemic absorption of iodine is greatly increased if the solutions are applied to broken skin, mucous membranes or are introduced into cavities of the body. At subcutaneous dose levels of up to 75mg/Kg/day, povidone-iodine was non-teratogenic in rabbits following administration to pregnant animals during the period of organogenesis.

Some early in vitro studies indicated a possible mutagenic action for povidone-iodine. However, a number of later studies, using in vitro and in vivo test systems, do not indicate a significant level of mutagenic/genotoxic activity for povidone-iodine. Although conflicting data have been published, there is no convincing evidence to suggest that povidone-iodine adversely affects wound healing. Concentration of 0.05 and 0.5% povidone-iodine did not cause significant ocular damage when administered into the vitreous cavities of rabbits' eyes. There is some evidence to suggest that povidone-iodine-containing solutions applied to the round window of the chinchilla ear could result in high frequency hearing loss.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Alkyl Phenol Ether Sulphate (Ammonium Salt)

Polyethylene glycol 400

Cocoamide DEA

Glycerol

PVP K90

Citric acid

Di-sodium phosphate, anhydrous

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 30°C in a dry place, protected from light.

6.5 Nature And Contents Of Container

Videne Surgical Scrub is packaged in a 500 ml HDPE bottle sealed with a plastic screw cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0042

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 2003

10. Date Of Revision Of The Text

August 2006


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Betadine Alcoholic Solution (Molnlycke Health Care )


1. Name Of The Medicinal Product

Betadine Alcoholic Solution.

2. Qualitative And Quantitative Composition

Povidone iodine 10.0% w/v.

3. Pharmaceutical Form

Alcoholic solution.

4. Clinical Particulars 4.1 Therapeutic Indications

For use as an antiseptic skin cleanser for major and minor surgical procedures where a quick drying effect is desired.

4.2 Posology And Method Of Administration

For topical administration.

4.3 Contraindications

Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

4.4 Special Warnings And Precautions For Use

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone iodine through either intact or damaged skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

4.6 Pregnancy And Lactation

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Povidone iodine may produce local skin reactions, although it is considered to be less irritant than iodine. The application of povidone iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.

4.9 Overdose

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment. Treatment: In the case of accidental ingestion of large quantities of Betadine symptomatic and supportive treatment should be provided, with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The active ingredient, povidone iodine, slowly liberates iodine when in contact with skin and mucous membranes. The activity of 'iodine' as a microbicide is then governed by a series of dissociations: I2? I+ + I- ; I2 + H2O ? H2O I+ + I- ; I2 + I- ? I3-. The microbicidal species H2O I+ preferentially displaces oxygen as the end electron acceptor in the microorganism's respiratory cycle. H2O I+ similarly interacts within the electron transport chain and reacts with the amino acids of the microbial cell membrane.

5.2 Pharmacokinetic Properties

Betadine Alcoholic Solution is for topical application and therefore a consideration of the absorption, distribution, metabolism and excretion of povidone iodine is largely without relevance.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Nonoxynol 9; dibasic sodium phosphate (anhydrous); citric acid monohydrate; glycerol; industrial methylated spirit; sodium hydroxide; purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

To be stored at or below 25 degrees Celsius and protected from light.

6.5 Nature And Contents Of Container

High-density polyethylene containers fitted with steran lined white polypropylene caps. Pack size: 500ml

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0002.

9. Date Of First Authorisation/Renewal Of The Authorisation

14th March 2005.

10. Date Of Revision Of The Text

March 2005.


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Betadine Surgical Scrub (Molnlycke Health Care )


1. Name Of The Medicinal Product

Betadine Surgical Scrub.

2. Qualitative And Quantitative Composition

Povidone Iodine 7.5% w/v.

3. Pharmaceutical Form

Surgical scrub.

4. Clinical Particulars 4.1 Therapeutic Indications

For use as an antiseptic cleanser for pre-operative scrubbing and washing by surgeons and theatre staff, and pre-operative preparation of patients' skin.

4.2 Posology And Method Of Administration

For topical administration. Adults, the elderly and children: Apply full strength as a pre-operative antiseptic skin cleanser. Povidone iodine is not recommended for regular use in neonates and is contraindicated in very low birth weight infants (below 1500 grams).

4.3 Contraindications

Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

4.4 Special Warnings And Precautions For Use

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone iodine through either intact or damaged skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

4.6 Pregnancy And Lactation

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Povidone iodine may produce local skin reactions although it is considered to be less irritant than iodine. The application of povidone iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.

4.9 Overdose

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and impairment of renal function. In the case of accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The active ingredient, povidone iodine, slowly liberates iodine when in contact with skin and mucous membranes. The activity of 'iodine' as a microbicide is then governed by a series of dissociations: I2? I+ + I- ; I2 + H2O ? H2O I+ + I- ; I2 + I- ? I3-. The microbicidal species H2O I+ preferentially displaces oxygen as the end electron acceptor in the microorganism's respiratory cycle. H2O I+ similarly interacts within the electron transport chain and reacts with the amino acids of the microbial cell membrane.

5.2 Pharmacokinetic Properties

Betadine Surgical Scrub is intended for topical application and therefore a consideration of the absorption, distribution, metabolism and elimination of povidone iodine is largely without relevance.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sulphated nonylphenoxypoly(oxyethylene) ethanol ammonium salt; lauric diethanolamide;

ethoxylated lanolin 50%; Natrosol HXR; sodium hydroxide; purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store below 25oC and protect from light.

6.5 Nature And Contents Of Container

High density polyethylene containers fitted with steran lined white polypropylene caps containing 500ml of product.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0009.

9. Date Of First Authorisation/Renewal Of The Authorisation

6th April 2005.

10. Date Of Revision Of The Text

April 2006.


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Betadine Dry Powder Spray (Molnlycke Health Care )


1. Name Of The Medicinal Product

Betadine Dry Powder Spray.

2. Qualitative And Quantitative Composition

Povidone Iodine 2.5% w/w.

3. Pharmaceutical Form

Pressurised aerosol spray.

4. Clinical Particulars 4.1 Therapeutic Indications

Antiseptic for the treatment and prevention of infection in wounds including ulcers, burns, cuts and other minor injuries.

4.2 Posology And Method Of Administration

For topical use only. Adults and children aged 2 years and over: Shake the can well before use. Spray the required area from a distance of 15-25cm (6-10 inches) until a dusting of powder is deposited. If necessary, the treated area may be covered with a dressing.

4.3 Contraindications

Hypersensitivity to iodine. Betadine Dry Powder Spray should not be used in serous cavities. Do not use this product regularly if the patient suffers from thyroid disorders or is receiving concurrent lithium therapy. Do not use on children under two years of age.

4.4 Special Warnings And Precautions For Use

Avoid inhaling or spraying into the eyes. Avoid use on patients with renal impairment. Should evidence of local irritation or sensitivity occur, use of the product should cease. If no improvement occurs, a doctor should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Use with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects.

4.6 Pregnancy And Lactation

Use in pregnancy or lactation should be limited. Although no adverse effects are anticipated from such limited usage, caution is recommended and therapeutic benefit must be balanced against the possible effects of the absorption of iodine on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin. Following prolonged application of Betadine Dry Powder Spray to severe burns or large areas of denuded skin, systemic effects such as metabolic acidosis, parametrical renal impairment and thyroid dysfunction may occur.

4.9 Overdose

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment.

Treatment: In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Povidone iodine is a complex of iodine which retains the broad-spectrum germicidal activity of the elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Isopropyl myristate; n-pentane; butane 40; soya lecithin.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store at or below 25oC.

6.5 Nature And Contents Of Container

Aerosol cans containing 100ml of product.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0005.

9. Date Of First Authorisation/Renewal Of The Authorisation

19th April 2006.

10. Date Of Revision Of The Text

April 2006.


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Betadine Skin Cleanser (Molnlycke Health Care )


1. Name Of The Medicinal Product

Betadine Skin Cleanser.

2. Qualitative And Quantitative Composition

Povidone Iodine USP 4.00% w/v.

3. Pharmaceutical Form

Topical aqueous solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Acne vulgaris of the face and neck. For general disinfection of the skin (as a liquid soap).

4.2 Posology And Method Of Administration

Route of administration: Topical. Adults, the elderly and children over 2 years: Apply directly or with moistened sponge to the affected areas and work up a rich lather. Allow to remain on the skin for 3-5 minutes then rinse off thoroughly with warm water and dry with a clean or sterile towel or gauze. Repeat twice daily. Infants under 2 years: Limit use to 2-3 days.

4.3 Contraindications

Hypersensitivity to iodine. History of abnormal thyroid function or goitre.

4.4 Special Warnings And Precautions For Use

Do not use on broken skin. Iodine is absorbed through burns and broken skin and, to a lesser extent, through intact skin. Restrict use in infants to 2-3 days.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use in pregnancy and lactation should be limited and although no adverse effects are anticipated from such limited usage, caution is recommended and the therapeutic benefit must be balanced against the possible effects of the absorption of iodine on foetal thyroid function.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

If local irritation or sensitivity develops, then discontinue treatment.

4.9 Overdose

Treatment: In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Betadine Skin Cleanser contains povidone iodine, a complex of iodine which shows all the broad-spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of exfoliative debris and infected lesions whilst the colour persists. Betadine Skin Cleanser kills bacteria, viruses, fungi, spores and protozoa.

5.2 Pharmacokinetic Properties

The product is intended for topical application.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified water; potassium iodate; NPPE ester; lauric diethanolamide; Natrosol HXR; Vah Floral Perfume No 2; sodium hydroxide.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store at a temperature not exceeding 25oC.

6.5 Nature And Contents Of Container

Polypropylene container with polypropylene lid containing 250ml.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0015.

9. Date Of First Authorisation/Renewal Of The Authorisation

30th March 2005.

10. Date Of Revision Of The Text

May 2006.


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Lugols Strong Iodine Solution



Dosage Form: solution
Lugols Strong Iodine Solution CONTENTS      

Iodine 0.05 g/ml, Potassium Iodide 0.105 g/ml.

DESCRIPTION      

LUGOL’S is an aqueous solution containing Iodine 5%, and potassium iodide 10%, w/v (LUGOL’s Solution). LUGOL’s is a transparent liquid with a deep brown color and the odor of iodine.

HOW SUPPLIED      

LUGOL’S is supplied in 8 ml glass single-use bottles.

INDICATIONS AND USAGE      

LUGOL’s is a topical antiseptic. Strong Iodine Solution is a germicide and fungicide. LUGOL’s is preservative-free.

ADMINISTRATION      

LUGOL’S is applied directly to areas needing antiseptic.

WARNINGS      

For External Use Only.

CONTRAINDICATIONS      

Iodide preparations are contraindicated in patients with known sensitivity to the drugs.

CAUTION      

Federal law restricts this device to sale by or on the order of a physician.

STORAGE      

Keep tightly closed. Protect from light.  DO NOT use if seal has been broken. Store at controlled room temperature 15°-30°C (59°-86°F).

DISPOSAL      

Opened containers with unused portions of product and applicator swabs containing residual product should be placed in a suitable, dry container for disposal following local hazardous waste practices. Waste containing LUGOL’S should not be subjected to any thermal process whether intended for destruction or recycling purposes.

PRINCIPAL DISPLAY PANEL

Lugol’s

Strong Iodine Solution USP

Contents      

One Dozen (12)

8ml Vials


LUGOLS STRONG IODINE 
iodine potassium iodide  solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59365-6064 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 0.05 g  in 1 mL POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 0.105 g  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 59365-6064-1 12 VIAL In 1 CARTON contains a VIAL, SINGLE-USE 1 8 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (59365-6064-1)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/01/1992
Labeler - CooperSurgical, Inc. (801895244) Revised: 11/2009CooperSurgical, Inc.
More Lugols Strong Iodine Solution resources Lugols Strong Iodine Solution Drug Interactions Lugols Strong Iodine Solution Support Group 0 Reviews · Be the first to review/rate this drug
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Udder Wash Concentrate175



Dosage Form: FOR ANIMAL USE ONLY

FOR COMMERCIAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

NOT FOR HUMAN USE

CAUTION

CAUTION

Harmful if swallowed, eye irritant.

FIRST:

Avoid contact with skin and eyes. Contact can cause severe irritation. Get medical attention. If ingested, drink

large amounts of water or milk. DO NOT induce vomiting. Get immediate attention. Avoid repeated contact with

skin and hands. Use rubber gloves to avoid skin irritation. If contact occurs, wash thoroughly with clean water.

EMERGENCY: CHEMTREC 800-424-9300

UDDER WASH #175 is a concentrated product containing a minimum of 1.75% titratable iodine.

UDDER WASH #175 diluted at one once per five gallons of water produces an efficient washing

solution of minimum of 25 parts per million (ppm).


Utter Wash Concntrate #175
Iodine Utter Wash
An aid in Reducing the Spread of Organisms
Which May Causes Mastitis
ACTIVE INGREDIENTS:
Iodine...........................................1.75%
INACTIVE INGREDIENTS..............98.25%
Wausau Chemical Corporation
2001 North River Drive
Wausau, WI 54403-0953 U.S.A.
UDDER WASH CONCENTRATE 175 
iodine  solution Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 64892-005 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 1.75 L  in 100 L Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 64892-005-16 18.9 L In 1 DRUM None 2 64892-005-17 56.78 L In 1 DRUM None 3 64892-005-18 113.6 L In 1 DRUM None 4 64892-005-21 208.2 L In 1 DRUM None 5 64892-005-88 1040 L In 1 CONTAINER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/14/2000
Labeler - Wausau Chemical (006136220) Establishment Name Address ID/FEI Operations Wausau Chemical 006136220 manufacture Revised: 09/2000Wausau Chemical

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Teat Dip 5000



Dosage Form: FOR ANIMAL USE ONLY

FOR COMMERCIAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

NOT FOR HUMAN USE

CAUTION

CAUTION

Harmful if swallowed, eye irritant.

FIRST AID:

Avoid contact with skin and eyes. Contact can cause severe irritation. Get medical attention. If ingested, drink large amounts of water or milk. DO NOT induce vomiting.

Get immediate attention. Avoid repeated contact with skin and hands. Use rubber gloves to avoid skin irritation. If contact occurs, wash thoroughly with clean water.

EMERGENCY: CHEMTREC 800-424-9300

Prior to milking, dip teats in undiluted Teat Dip 5000. Wipe off with a clean towel after 15 to 30 seconds.

After milking apply Teat Dip 5000 by dipping. Do not rinse or wash off. Allow teats to dry before letting cows

outdoors in cold weather to guard against chapping.


Teat Dip 5000
Iodine Teat Dip
An aid in Reducing the Spread of Organisms
Which May Cause Mastitis
ACTIVE INGREDIENTS:
Iodine..................................................0.5%
INACTIVE INGREDIENTS....................99.5%
Teat Dip 5000 
iodine  solution Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 64892-002 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 0.5 L  in 100 L Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 64892-002-16 18.9 L In 1 DRUM None 2 64892-002-17 56.78 L In 1 DRUM None 3 64892-002-18 113.6 L In 1 DRUM None 4 64892-002-21 208.2 L In 1 DRUM None 5 64892-002-88 1040 L In 1 DRUM None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/14/2000
Labeler - Wausau Chemical (006136220) Establishment Name Address ID/FEI Operations Wausau Chemical 006136220 manufacture Revised: 09/2000Wausau Chemical

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Iodine Tincture BP


1. Name Of The Medicinal Product

Alcoholic Iodine Solution BP

Iodine Tincture BP

2. Qualitative And Quantitative Composition

Iodine 2.5% w/v, Potassium Iodide 2.5% w/v

3. Pharmaceutical Form

Cutaneous solution.

A dark brown, clear, mobile liquid.

4. Clinical Particulars 4.1 Therapeutic Indications

As an antiseptic for use on minor wounds, cuts and abrasions.

4.2 Posology And Method Of Administration

For cutaneous use.

The product is suitable for use by adults, children and the elderly.

Apply to the affected part with cotton wool or a small brush.

4.3 Contraindications

Contraindicated for patients hypersensitive to iodine or iodides.

Contradicted for use in newborn infants.

Contradicted in patients with thyroid disorders or those receiving lithium therapy.

4.4 Special Warnings And Precautions For Use

Avoid prolonged use.

For external use only.

Keep all medicines out of the reach and sight of children.

Solutions of iodine applied to the skin should not be covered with occlusive dressings, (otc packs to state the shortened warning, “DO NOT COVER”).

Do not use on large, open wounds.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Administration of this product may interfere with tests of thyroid function.

4.6 Pregnancy And Lactation

Use with caution during pregnancy and lactation. Iodides cross the placenta and are excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

None or negligible influence.

4.8 Undesirable Effects

May cause allergic reactions, including urticaria, angioedema, cutaneous haemorrhage or purpuras, fever, arthralgia, lymphadenopathy and eosinophilia.

4.9 Overdose

This product is not intended for internal use.

Symptoms of acute poisoning from ingestion of iodine include a disagreeable metallic taste, vomiting, abdominal pain and diarrhoea, thirst and headache may occur. The fatal dose of iodine is 2 to 3g. Symptomatic treatment for allergic reactions and iodism may be required, although symptoms usually subside rapidly when administration of iodine or iodide is stopped.

In acute poisoning copious draughts of milk and starch mucilage should be given.

Lavage should probably not be attempted and certainly not unless iodine had been ingested in sufficiently dilute form not to produce gastrointestinal corrosion. Other treatments include activated charcoal and sodium thiosulphate solution 1% or 5% to reduce iodine to the less toxic iodides. Electrolyte and water losses should be replaced and the circulation should be maintained. Pethidine or morphine sulphate may be given for pain, under medical supervision. A tracheotomy may become necessary.

Provided the product is not applied to large, open wounds or used for prolonged periods, clinically significant systemic absorption is unlikely. Systemic toxicity may lead to shock, tachycardia, fever, metabolic acidosis and renal impairment Death may be due to circulatory failure, oedema of the epiglottis resulting in asphyxia, aspiration pneumonia or pulmonary oedema. Oesophageal stricture may occur if the patient survives the acute stage.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

D08A G03 - Antiseptics and disinfectants, iodine products

Iodine has a powerful bactericidal action and is used for disinfecting unbroken skin before operations. Iodine is active against fungi, viruses, protozoa, cysts and spores.

5.2 Pharmacokinetic Properties

Iodine is only slightly absorbed when applied to the skin.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified water

Ethanol (96%)

6.2 Incompatibilities

None known.

6.3 Shelf Life

25ml:

36months unopened

50ml:

36Months unopened

500ml:

36 Months unopened

2000ml:

36 Months unopened

6.4 Special Precautions For Storage

Store below 25°C in a well closed container.

6.5 Nature And Contents Of Container

25ml:

Glass bottle with plastic lined cap

50ml:

Glass bottle with plastic lined cap

500ml:

Glass bottle with plastic lined cap

2000ml:

Glass bottle with plastic lined cap

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd.,

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0019

9. Date Of First Authorisation/Renewal Of The Authorisation

25th August 1993

10. Date Of Revision Of The Text

06/08/2009


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